Long-term Exercise, Weight Loss and Energy Balance

NCT01186523 | Completed DMC

• 2 other identifiers: HSCL15226R01DK049181
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

In order to examine potential gender differences in the weight loss response to exercise, the investigators propose to compare equal energy expenditure of exercise for overweight men and women using levels of exercise energy expenditure that the investigators have previously shown to prevent weight gain or promote weight loss. The investigators will randomize men and women to an exercise group, 5 days/week, for 9 months, with an energy expenditure of 400 kcal/exercise session, a group with 600 kcal/ exercise session, or a control group. 1)The investigators hypothesize that men and women randomized to sedentary control will gain weight, those randomized to 400 kcal/exercise session will maintain weight (will not gain), and those randomized to 600 kcal/exercise session will lose \~5% of body weight. 2) The investigators hypothesize there will be no differences for weight loss between genders at either 400 or 600 kcal of energy expenditure of exercise since men and women will have equal amounts of energy expenditure of exercise. 3) The investigators hypothesize that men and women randomized to 400 kcal/exercise session will completely compensate for the energy expended during exercise by altering energy intake and/or spontaneous activity and that men and women participants randomized to 600 kcal/exercise session will not completely compensate. The investigators believe the findings from this study could have important implications for exercise guidelines for weight loss.

Conditions

Obesity

Keywords

Obesity; Weight Management; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Between group weight change at 10 months

  10 months

Secondary Outcomes (3)

• Body Composition

  10 months

• Resting Metabolic Rate

  10 months

• Total Daily Energy Expenditure

  10 months

Study Arms (3)

400 kcal of exercise/session

EXPERIMENTAL

400 kcal of exercise/session

Other: Long Term Energy Balance

600 Kcal of exercise/session

EXPERIMENTAL

600 Kcal of exercise/session

Other: Long Term Energy Balance

Control, no exercise

EXPERIMENTAL

No exercise control group

Other: Long Term Energy Balance

Interventions

Long Term Energy Balance OTHER

To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.

Also known as: 400 kcal of exercise/session, 600 kcal of exercise/session, No exercise control group

400 kcal of exercise/session; 600 Kcal of exercise/session; Control, no exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or greater
• males \& females
• \<500kcal exercise/wk
• BMI 25-40

You may not qualify if:

• known cardiovascular and metabolic disorders,
• weight altering product use
• smoking
• clinical depression
• special diets

Sponsors & Collaborators

• University of Kansas: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (3)

• Herrmann SD, Willis EA, Honas JJ, Lee J, Washburn RA, Donnelly JE. Energy intake, nonexercise physical activity, and weight loss in responders and nonresponders: The Midwest Exercise Trial 2. Obesity (Silver Spring). 2015 Aug;23(8):1539-49. doi: 10.1002/oby.21073.

  PMID: 26193059 DERIVED

• Ptomey LT, Willis EA, Honas JJ, Mayo MS, Washburn RA, Herrmann SD, Sullivan DK, Donnelly JE. Validity of energy intake estimated by digital photography plus recall in overweight and obese young adults. J Acad Nutr Diet. 2015 Sep;115(9):1392-9. doi: 10.1016/j.jand.2015.05.006. Epub 2015 Jun 26.

  PMID: 26122282 DERIVED

• Donnelly JE, Honas JJ, Smith BK, Mayo MS, Gibson CA, Sullivan DK, Lee J, Herrmann SD, Lambourne K, Washburn RA. Aerobic exercise alone results in clinically significant weight loss for men and women: midwest exercise trial 2. Obesity (Silver Spring). 2013 Mar;21(3):E219-28. doi: 10.1002/oby.20145.

  PMID: 23592678 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joseph E Donnelly, EdD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: July 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

US (1)